Nabriva Therapeutics to Present Data at ASM/ESCMID Conference Demonstrating Utility of Xenleta™ (lefamulin) for Patients with Community-Acquired Bacterial Pneumonia (CABP)
“We are committed to providing patients and their treating physicians, novel anti-infective treatment options that are both well-tolerated and effective and help to address the growing global threat of antimicrobial resistance,” said Jennifer Schranz MD, Chief Medical Officer of Nabriva Therapeutics. “At ASM/ESCMID, we will present data from the lefamulin clinical program that further support the safety and efficacy of lefamulin for the treatment of adult patients with CABP.”
Highlights of the data to be presented at
Poster Presentation Session
- Poster T-18 - Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Efficacy Based on Data from Lefamulin-Treated Patients Enrolled in Phase 3 Studies for Community-Acquired Bacterial Pneumonia (CABP).
In a study evaluating PK‐PD relationships for efficacy using data from lefamulin‐treated patients with CABP from two phase 3 trials, efficacy results of these analyses provide support for the lefamulin dosing regimens of 150 mg IV q12h and 600 mg PO q12h for the treatment of adult patients with CABP.
- Poster T-19 – Pharmacokinetic-Pharmacodynamic Target Attainment Analyses to Support Lefamulin Dose Justification and Susceptibility Breakpoint Determinations for Patients with Community-Acquired Bacterial Pneumonia
A population PK model was further refined utilizing PK data collected in phase 3 from CABP patients, nonclinical PK-PD targets for efficacy and in vitro surveillance data with Monte Carlo simulation to perform PK-PD target attainment analyses for dose justification. Results provide support for selection of lefamulin 150 mg IV q12h and 600 mg PO q 12 h in patients for treatment of CABP with or without regard to food.
- Poster T-20 - Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Alanine Aminotransferase (ALT) Using Phase 2 and 3 Data from Lefamulin-Treated Patients
PK‐PD relationships for ALT were evaluated using phase 2 and 3 data from lefamulin‐treated patients. While a covariate‐adjusted relationship between increased ALT and increased lefamulin AUC was found, model‐predicted ALT elevation endpoints across fixed lefamulin AUC values, or among simulated patients after administration of lefamulin IV or PO dosing regimens relative to observed patients, were minimal.
- Poster T-74 -Lefamulin (LEF) Activity against Gram-Positive Pathogens Collected in the 2017 Global SENTRY Surveillance Program
The objective of this study was to evaluate the in vitro activity of lefamulin and comparators against a contemporary global set of Gram-positive pathogens. As part of the 2017 global SENTRY Antimicrobial Surveillance Program, 4337 unique isolates (34 countries, 98 sites) were collected from patients with community-acquired respiratory tract infections (40.0%), hospitalized patients with pneumonia (13.6%), bloodstream infections (23.2%), skin and soft tissue infections (18.7%), and other infections (4.5%). Lefamulin showed potent antibacterial activity against all tested pathogens, and its activity was unaffected by resistance to other antibiotic classes including macrolides, fluoroquinolones or beta-lactam antibiotics.
The abstracts can be accessed through the
ASM/ESCMID Conferencewebsite. Following the meeting, the posters will be available on the Nabriva website.
Any statements in this press release about future expectations, plans and prospects for
Source: Nabriva Therapeutics US, Inc